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Chemoprophylaxis for leprosy: comparing the effectiveness and feasibility of a skin camp intervention to a health centre-based intervention

Chemoprophylaxis for leprosy: comparing the effectiveness and feasibility of a skin camp intervention to a health centre based intervention. An implementation trial in Mozambique, Ethiopia and Tanzania.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27622
Enrollment
30000
Registered
2018-09-10
Start date
2019-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leprosy, lepra, Hansen's disease, skin diseases, dermatological conditions, NTDs

Interventions

One intervention will be community based, using skin camps to screen around 100 contacts of an leprosy index patients and provide them with SDR-PEP when eligible. The other intervention will be health
other skin diseases, such as common skin diseases and neglected tropical diseases (NTDs) manifesting skin lesions, will also be diagnosed and treated. The project will contribute to health system stre

Sponsors

This project was supported by the EDCTP2 program under Horizon 2020 (grant number RIA2017NIM-1839-441 PEP4LEP). The project also received funding from the Leprosy Research Initiative (LRI; www.leprosyresearch.org) under LRI grant number 707.19.58.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Index patients: - Consent to participate in the PEP4LEP project - Diagnosed with leprosy (preferred maximum of 6 months prior to inclusion) - Residence in the PEP4LEP districts for =3 months prior to the date of diagnosis - Index patient has started MDT - Community-based skin camp intervention: Leprosy patient gives permission for the set-up of a skin camp in his/her community (sharing their leprosy diagnosis with their contacts is not needed) - Health center-based household screening intervention: Leprosy patient with household contacts, and who is willing to inform these contacts about PEP4LEP Contacts: - Consent to participate in the PEP4LEP project - Community-based skin camp intervention: Community contact of the index patient for =3 months - Health center-based household screening intervention: Contact which is a household member of the index patient for =3 months, visiting the screening health center =3 months after the index patient was included The eligibility criterium for aditional stakeholders (community leaders, health workers, community health volunteers and health policy decision maker, contacts refusing SDR-PEP) taking part in the acceptability evaluation and the capacity assessment is providing consent to participate in the PEP4LEP project

Exclusion criteria

Exclusion criteria: Index patients: - Index patient or parents/legal guardians unable to understand the purpose and risks of participating in the PEP4LEP study Contacts: - Contact or parents/legal guardians unable to understand the purpose and risks of participating in the PEP4LEP study - Age <2 years and/or <10 kg of weight* - Pregnancy* - Receiving or having received rifampicin for any reason in the last 2 years - Known allergy to rifampicin - History of liver or renal disorders - Individuals with leprosy and those who have possible signs and/or symptoms of leprosy (e.g., leprosy-like skin lesions or nerve manifestations) until their disease status has been clarified** - Individuals with possible signs and/or symptoms of TB (cough for more than two weeks or cough in known HIV/AIDS patients, night sweats, unexplained fever, weight loss) until their disease status has been clarified *** - Individuals with possible signs and/or symptoms of COVID-19 (self-assessed temperature =38°C, respiratory or cold-like symptoms, sudden loss of smell/taste) or possible contact with a COVID-19 patient in the past 14 days*** * A voucher will be given for repeated skin screening and SDR-PEP. This can be used in a PEP4LEP affiliated health center when this person becomes eligible (e.g., after giving birth) ** If referral was needed and no leprosy is detected, repeated skin screening and SDR-PEP can be provided in a PEP4LEP affiliated health center *** Skin screening and SDR-PEP can only be provided in a PEP4LEP affiliated health center after the contact is tested negative for COVID-19/TB (according to national guidelines)

Design outcomes

Primary

MeasureTime frame
•To compare the effectiveness of a skin camp prophylaxis intervention to a health centre-based prophylaxis intervention in terms of the rate of leprosy patients detected and delay in case detection •To compare the feasibility of the two chemoprophylaxis interventions (screening household contacts or screening contact via skincamp) in terms of cost effectiveness and acceptability

Secondary

MeasureTime frame
• To assess the acceptability of a common skin diseases approach and the use of the SkinApp • To compare the capacity of health workers in diagnosing leprosy and other NIDs that manifest with skin lesions before the start of the study with their capacity in the third year

Contacts

Public ContactAnne Schoenmakers

NLR

pep4lep@nlrinternational.org+31(0)20-5950500

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)